EUCTR2012-000454-58-BE进行中（未招募）不适用
Prospective, monocentre phase I study of sequential infusion of Y90-labeled microspheres and Mitomycine C in patients with chemorefractory liver metastases from breast carcinoma
niversity Hospitals Leuven0 个研究点开始时间: 2012年3月22日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Histologically confirmed diagnosis of breast cancer
- •Radiological evidence of liver metastases
- •Liver-only or liver predominant disease
- •Progressive under (multi-line) systemic chemotherapy
- •Progressive under hormonotherapy for hor+ patients.
- •Patients scheduled for mitomycine chemoinfusion
- •Liver/lung shunt < 20% as determined by the Tc99-scan
- •Age older than 18 years
- •Karnovski >=70
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •. Karnovsky < 70
- •. Biochemical evidence of severe haematological toxicity and liver function test disturbances (Bilirubine > 1.5; AST/ALT > 2.5 fold normal range; Creatinine > 1.2 upper normal limit; GFR (glomerular filtration rate) < 60)
- •. Neutrophiles < 1000/ml
- •. Thrombocytes < 100.000
- •. Liver/lung shunt > 20% as determined by the Tc99-scan
- •. Allergy to contrast media
- •. Intake of oral anticoagulation
研究者
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